Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Surgical Site Infection Clinical Trial

Official title:

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580472
• Other study ID #: IRB-19-482
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: September 2022

Study information

• Verified date: August 2022
• Source: Carilion Clinic
• Contact: Mariana Phillips, MD
• Phone: 540-224-5170
• Email: maphillips[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be a double blinded, placebo-controlled clinical trial. Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin). Patients will followed for 30 days +/- 7 after surgery to evaluate for any surgical site infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• presenting to Carilion Clinic Dermatology and Mohs surgery in Roanoke, VA at Riverside 1
• suspected to undergo a single-staged repair including a skin flap or graft on the nose
• OR suspected to undergo single-staged repair including a skin graft or flap or wedge resection 1 on the ear
• OR undergoing Mohs with closure or partial closure or surgical excision on the lower extremity below the knee

Exclusion Criteria:

• patients with intellectual or mental impairment affecting ability to give informed consent
• use of any antibiotic (other than intervention) within 48 hours of the surgery suspected infection at time of surgery
• inability to take cephalexin or clindamycin hydrochloride due to allergy or intolerance current inflammatory skin disease affecting the surgical site
• Patients undergoing concurrent surgery to oral or nasal mucosa
• Patients who have had a recent prosthetic joint surgery within two years and have been told they require antibiotic prophylaxis.
• Patients who are currently pregnant, concerned they could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by a birth control method.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Cephalexin
If randomized to the antibiotic group, a single dose of cephalexin or clindamycin hydrochloride (if concern for previous allergy to Cephalexin) will be given prior to surgery.

Other:
• Placebo capsules
Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of surgical site infection within 30 days of surgery	Rate of surgical site infection occurrence	30 days